Approval of change in the liaison quantiferon-tb gold plus assay protocol reagent dispensation sequence. Based upon the information submitted, the pma supplement is approved.
| Device | LIAISON QuantiFERON TB Gold Plus |
| Generic Name | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis |
| Applicant | DiaSorin, Inc. |
| Date Received | 2020-06-04 |
| Decision Date | 2020-07-23 |
| PMA | P180047 |
| Supplement | S003 |
| Product Code | NCD |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DiaSorin, Inc. 1951 Northwestern Avenue stillwater, MN 55082-0285 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180047 | | Original Filing |
| S022 |
2022-11-10 |
30-day Notice |
| S021 | | |
| S020 | | |
| S019 | | |
| S018 |
2022-07-15 |
30-day Notice |
| S017 |
2022-04-13 |
Real-time Process |
| S016 |
2022-04-05 |
Real-time Process |
| S015 |
2022-04-05 |
30-day Notice |
| S014 |
2022-02-04 |
Real-time Process |
| S013 |
2021-11-23 |
30-day Notice |
| S012 | | |
| S011 | | |
| S010 |
2021-05-27 |
Real-time Process |
| S009 | | |
| S008 | | |
| S007 | | |
| S006 |
2020-08-25 |
Real-time Process |
| S005 |
2020-07-16 |
30-day Notice |
| S004 |
2020-06-18 |
Real-time Process |
| S003 |
2020-06-04 |
Real-time Process |
| S002 |
2020-02-13 |
Real-time Process |
| S001 | | |
NIH GUDID Devices